Pravastatin Sodium

In shortageOrange BookUNIISPLATC C10AA03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerChartwell RX, LLC

CountryUS (United States)

ATC codeC10AA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6213584790
90 TABLET, FILM COATED in 1 BOTTLE (62135-847-90)

Annotations

UNII (FDA Substance ID)

3M8608UQ61

PRAVASTATIN SODIUM

RxCUI 203144

Orange Book

A077917

ABABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Pravastatin Sodium Tablet

Raw payload (JSON)

{
  "unii": {
    "unii": "3M8608UQ61",
    "rxcui": "203144",
    "inchikey": "VWBQYTRBTXKKOG-IYNICTALSA-M",
    "display_name": "PRAVASTATIN SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "dcf46d0c-87da-4009-b238-eb5cf287c3ed": {
      "match": "brand_token",
      "title": "PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2026-06-01"
    }
  },
  "productid": "62135-847_2cf16f1b-c67f-455e-e063-6394a90adc0a",
  "productndc": "62135-847",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077917",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jan 8, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Jan 8, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "003",
        "approval_date": "Jan 8, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "004",
        "approval_date": "Jan 8, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRAVASTATIN SODIUM",
  "shortage_reason": "Pravastatin Sodium Tablet",
  "shortage_status": "current",
  "proprietary_name": "Pravastatin Sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077917",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pravastatin Sodium",
  "start_marketing_date": "20240926",
  "active_numerator_strength": "10"
}

Related drugs

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